Trial Outcomes & Findings for The Effect of Omeprazole on the Pharmacokinetics of Dasatinib in Healthy Subjects (NCT NCT00655746)

NCT ID: NCT00655746

Last Updated: 2009-12-15

Results Overview

Pharmacokinetics is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. Cmax=maximum observed plasma concentration of dasatinib

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 14 participants
• Primary outcome timeframe: Day 1 and Day 6 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours post dose
• Results posted on: 2009-12-15

Participant Flow

49 participants were enrolled in the study, and 35 discontinued before being treated (26 no longer met study criteria, 6 withdrew consent, 3 group full/not needed)

Participant milestones

Measure	Dasatinib/Omeprazole Day 1: 100-mg oral dasatinib; Days 2 through 6: 40-mg oral omeprazole; Day 6:100-mg oral dasatinib and 40-mg oral omeprazole
Overall Study STARTED	14
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Dasatinib/Omeprazole Day 1: 100-mg oral dasatinib; Days 2 through 6: 40-mg oral omeprazole; Day 6:100-mg oral dasatinib and 40-mg oral omeprazole
Overall Study Withdrawal by Subject	1

Baseline Characteristics

The Effect of Omeprazole on the Pharmacokinetics of Dasatinib in Healthy Subjects

Baseline characteristics by cohort

Measure	Dasatinib/Omeprazole n=14 Participants Day 1: 100-mg oral dasatinib; Days 2 through 6: 40-mg oral omeprazole; Day 6:100-mg oral dasatinib and 40-mg oral omeprazole
Age Continuous	37 years STANDARD_DEVIATION 6 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Race/Ethnicity, Customized Black	8 participants n=5 Participants
Race/Ethnicity, Customized White	5 participants n=5 Participants
Race/Ethnicity, Customized Asian	1 participants n=5 Participants
Body Mass Index (BMI)	25.4 kg/m2 STANDARD_DEVIATION 2.9 • n=5 Participants

PRIMARY outcome

Timeframe: Day 1 and Day 6 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours post dose

Pharmacokinetics is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. Cmax=maximum observed plasma concentration of dasatinib

Outcome measures

Measure	Dasatinib (Day 1) n=14 Participants 100-mg oral dasatinib	Dasatinib + Omeprazole (Day 6) n=13 Participants 100-mg oral dasatinib and 40-mg oral omeprazole	Dasatinib + Omeprazole (Day 6) 100-mg oral dasatinib and 40-mg oral omeprazole	All Participants
Dasatinib Pharmacokinetic (PK) Parameter: Maximum Observed Plasma Concentration (Cmax)	65.58 ng/mL Full Range 51 • Interval 3.17 to 150.81	38.64 ng/mL Full Range 76 • Interval 1.96 to 146.78	—	—

PRIMARY outcome

Timeframe: Day 1 and Day 6 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours post dose

Pharmacokinetics is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. Tmax=time of maximum observed plasma concentration

Outcome measures

Measure	Dasatinib (Day 1) n=14 Participants 100-mg oral dasatinib	Dasatinib + Omeprazole (Day 6) n=13 Participants 100-mg oral dasatinib and 40-mg oral omeprazole	Dasatinib + Omeprazole (Day 6) 100-mg oral dasatinib and 40-mg oral omeprazole	All Participants
Dasatinib PK Parameter Time of Maximum Observed Plasma Concentration(Tmax)	0.75 hours Interval 0.47 to 2.02	1.00 hours Interval 0.5 to 1.92	—	—

PRIMARY outcome

Timeframe: Day 1 and Day 6 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours post dose

Pharmacokinetics is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. T-Half=plasma half-life

Outcome measures

Measure	Dasatinib (Day 1) n=14 Participants 100-mg oral dasatinib	Dasatinib + Omeprazole (Day 6) n=13 Participants 100-mg oral dasatinib and 40-mg oral omeprazole	Dasatinib + Omeprazole (Day 6) 100-mg oral dasatinib and 40-mg oral omeprazole	All Participants
Dasatinib PK Parameter: Plasma Half-Life (T-HALF)	4.00 hours Standard Deviation 1.35	4.29 hours Standard Deviation 1.62	—	—

PRIMARY outcome

Timeframe: Day 1 and Day 6 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours post dose

area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC[0-T])for dasatinib

Outcome measures

Measure	Dasatinib (Day 1) n=14 Participants 100-mg oral dasatinib	Dasatinib + Omeprazole (Day 6) n=13 Participants 100-mg oral dasatinib and 40-mg oral omeprazole	Dasatinib + Omeprazole (Day 6) 100-mg oral dasatinib and 40-mg oral omeprazole	All Participants
Dasatinib PK Parameter: Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC[0-T])	249.46 ng∙h/mL Interval 42.42 to 531.26	137.49 ng∙h/mL Interval 14.03 to 453.41	—	—

PRIMARY outcome

Timeframe: Day 1 and Day 6 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours post dose

Pharmacokinetics is a branch of pharmacology concerned with the rate at which drugs are absorbed, distributed, metabolized, and eliminated by the body. AUC(INF)=area under the plasma concentration-time curve from time zero extrapolated to infinite time

Outcome measures

Measure	Dasatinib (Day 1) n=14 Participants 100-mg oral dasatinib	Dasatinib + Omeprazole (Day 6) n=13 Participants 100-mg oral dasatinib and 40-mg oral omeprazole	Dasatinib + Omeprazole (Day 6) 100-mg oral dasatinib and 40-mg oral omeprazole	All Participants
Dasatinib PK Parameters: Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUC[INF])	265.40 ng∙h/mL Interval 51.18 to 542.97	152.84 ng∙h/mL Interval 19.61 to 460.78	—	—

SECONDARY outcome

Timeframe: At Informed Consent (within 21 days of Day 1) through Study Discharge (Day 7)

An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a patient or clinical investigation subject administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.

Outcome measures

Measure	Dasatinib (Day 1) n=14 Participants 100-mg oral dasatinib	Dasatinib + Omeprazole (Day 6) n=14 Participants 100-mg oral dasatinib and 40-mg oral omeprazole	Dasatinib + Omeprazole (Day 6) n=13 Participants 100-mg oral dasatinib and 40-mg oral omeprazole	All Participants n=14 Participants
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations Number of Participants with ≥1 AE	3 Participants	2 Participants	2 Participants	4 Participants
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations Death	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations SAE	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations Discontinuation due to AEs	0 Participants	0 Participants	0 Participants	0 Participants

Adverse Events

BMS-354825 + Omeprazole

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	BMS-354825 + Omeprazole n=14 participants at risk
Nervous system disorders HEADACHE	21.4% 3/14
Gastrointestinal disorders NAUSEA	7.1% 1/14
Gastrointestinal disorders VOMITING	7.1% 1/14
Gastrointestinal disorders FLATULENCE	7.1% 1/14

Additional Information

BMS Study Director

Bristol-Myers Squibb

Email: Clinical.Trials@bms.com

Results disclosure agreements

• Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
• Publication restrictions are in place

Restriction type: OTHER